Bone implants and cutting apparatuses and methods

ABSTRACT

Implant devices and cutting clamp apparatuses and methods for creating the implants for insertion into a patient&#39;s joint to restore anatomic length and assist in final positioning of the bones following removal of cartilage and/or bone in preparation for fusion. A first implant is a biplanar implant having a shape to mimic the normal anatomical shape of the bones the implant is configured to mate with. The first implant may be cut using a cutting clamp and jig having the anatomical shape of the bones the implant will be inserted within or between. A second implant is a cylindrical piece of bone having a convex end and a concave end for mating with bones reamed to have the opposite mating surfaces. The second implant is created using cup and cone reamers having dimensions corresponding to the size of the patient&#39;s bones. Surgical methods for inserting the implants within a patient.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/260,836 filed on Sep. 9, 2016, which will issue as U.S. Pat. No.9,848,893 on Dec. 26, 2017, which is a divisional application of U.S.patent application Ser. No. 14/110,536 filed on Oct. 8, 2013, whichissued as U.S. Pat. No. 9,452,057 on Sep. 27, 2016, which is a nationalstage filing under section 371 of International Application No.PCT/US2012/032765 filed on Apr. 9, 2012, and published in English onOct. 11, 2012 as WO 2012/139114, and which claims priority benefit under35 U.S.C. § 119(e) of U.S. provisional patent application No. 61/473,194filed Apr. 8, 2011, which are each incorporated herein by reference intheir entireties.

TECHNICAL FIELD

This present disclosure relates generally to the field of orthopaedicsrelated to restoring anatomic length to joints between two bones in theupper and lower extremity following revision surgery, large deformities,injuries, and/or generally short anatomy.

BACKGROUND

The Lapidus procedure is commonly used to correct a hallux valgusdeformity, which is a lateral deviation of the great toe, withsubsequent hypermobility (or laxity). The Lapidus procedure is alsocommonly used to repair failed surgeries. Typically, a wedge of bone isremoved in a biplanar direction at the distal end of the cuneiform,which will provide correction of the deformity and typically results inshortening of the great toe. The result of this shortening is a shift inweight distribution to the second ray, which can result inmetatarsalgia. When the first ray is shortened the function of thepatient's sesamoids may also be affected because of the change in weightdistribution on the sesamoids. Currently to correct the shortening ofthe great toe when doing a Lapidus procedure, the accepted practice isfor surgeons to make straight transverse cut on the metatarsal, then cuta wedge out of the cuneiform to obtain realignment of theintermetatarsal angle as determined by the surgeon, and insert a blockof bone into the joint. The block of bone is then shaped by the surgeonuntil it fits within the joint. The shape of bone fails to help correctthe angle. Blood supply to this joint can be limited in certain patientsand using the overly processed bone makes it difficult to incorporateand heal which makes the bone prone to failure. It is well known thatblood supply consideration to the joint and anatomical height and weightbearing through the joint are all concerns for healing the Lapidusprocedure.

The metatarsal-phalangeal joint, when fused, is commonly denuded ofcartilage by either using cup and cone reamers to minimize a loss oflength and to provide versatility in final positioning or by makingtransverse type cuts using a saw blade. Generally, the cartilagesurfaces of the metatarsal and proximal phalanx are removed and the endof the proximal phalanx is aligned with the end of the metatarsal withthe two bones being fused together using screws, wires, or plates. Inthe case of revision surgeries of the metatarsal-phalangeal joint, thefirst ray may be shortened by 5-10+mm.

Accordingly, it is an object of the present invention to overcome one ormore of the above-described drawbacks and/or disadvantages of the priorart. For example, in view of the deficiencies of the current implantsand methods of performing the Lapidus procedure and fusion of themetatarsal-phalangeal joint, and similar implants and surgical methodsfor other areas of the body where multiple bone structures existincluding, but not limited to, the hand, wrist and spine, it would bedesirable to develop devices, instrumentation, and methods to allow asurgeon to achieve a satisfactory long term, predictable clinicaloutcome for these types of correction surgeries.

SUMMARY

The present invention is directed toward devices, instruments, andmethods for cutting and inserting implants in the upper and lowerextremity.

In one aspect of the present invention provided herein, is an implantfor insertion into a patient's joint. This implant may be used forexample during a Lapidus procedure. The implant having a body portionwhich is oblong. The implant is also tapered from the medial side to thelateral side of the implant as well as from the dorsal side to theplantar side of the implant. The implant may be made of metal, bone,polymer, or composite. For example, the implant may be made of titanium,cancellous bone, or polyetheretherketone.

In another embodiment of the present invention provided herein, is animplant device for replacing a joint. This implant may be used forexample in the metatarsal-phalangeal joint. The implant device having abody portion with a cylindrical shape and a first end with a concaveshape and a second end with a convex shape. The implant may be made ofmetal, bone, polymer, or composite, such as titanium, cancellous bone,or polyetheretherketone.

In another aspect of the present invention provided herein, is asurgical method for implanting an implant device into a joint, such asduring a Lapidus procedure. The implant device having medial, lateral,dorsal, and plantar sides and wherein the implant device is tapered fromthe medial side to the lateral side and from the dorsal side to theplantar side creating a biplanar implant. The method including exposingthe joint of a patient and preparing a first bone from a second bone toreceive the implant then the implant is inserted between the first andsecond bones. The first and second bones may be prepared by denudationof the cartilage between the first and second bone. Once prepared thebone removed is determined and an appropriate size restoration wedge isselected and implanted. After the bone wedge is implanted, appropriatefixation is determined and applied. The method may also include fixing afixation device, such as a plate, screws, wires, or external fixation tothe first bone and second bone.

Yet another aspect of the present invention provided herein, is asurgical method for implanting an implant device having a concave endand a convex end into a joint, such an implant may be used in themetatarsal-phalangeal joint. The method includes exposing the joint of apatient and preparing a first bone from a second bone. The methodfurther may include reaming the first bone and the second bone andinserting the implant device between the first bone and second bone. Themethod may also include fixing a fixation device to the first bone andsecond bone over the implant device. The first bone may be reamed tohave a convex shape and the second end to have a concave shape.Alternatively, the first bone may be reamed to have a concave shape andthe second bone to have a convex shape.

In a further aspect of the present invention provided herein, is acutting clamp for cutting a length of bone for use in creating animplant. The cutting clamp may include a first clamp having attachmentsites for top and bottom jaw members which are used to clamp a piece ofbone during cutting of the general outline of the shape of the jawmembers. The cutting clamp may further include a second clamp forattachment to the top and bottom jaw members on the side opposite thefirst clamp for cutting of the remaining general outline of the shape ofthe jaw members after removal of the first clamp to create a length ofbone having a shape corresponding to the top and bottom jaw members.

In another aspect of the present invention provided herein, is a cuttingjig for cutting an implantable device. The cutting jig includes ahousing having an opening for inserting the length of bone cut by thecutting clamps and a screw for securing the length of bone to thecutting jig during cutting of the bone implant.

In yet another aspect of the present invention provided herein, is amethod of cutting a length of bone for creating an implant. The methodincludes clamping a piece of bone between the top and bottom jaw membersof a first clamp. Cutting a general outline of the shape of the jawmembers into the piece of bone by tracing the exterior surface of thejaw members with a saw. Then the second clamp is attached to the jawmembers and secures the piece of bone between the jaw members. The firstclamp may then be removed and the second side of the piece of bone maybe cut by tracing around the exterior surface of the jaw members with asaw. Once the entire general outline of the jaw members has been traced,the second clamp may be removed leaving a length of bone having the sameshape as the jaw members. The method may further include obtaining acutting jig to cut a bone implant from the length of bone. The length ofbone is inserted into the opening of the cutting jig having a shapeidentical to the shape of the length of bone. Once the length of bone isinserted into the opening of the cutting jig, a screw may secure thelength of bone to the cutting jig. Then the length of bone may be cut byrunning a saw along the planar surfaces of the cutting jig to create thebone implant having a desired angulation.

In still another embodiment of the present invention provided herein, isa method of cutting a length of bone to create an implant device. Themethod including shaping a length of bone into a cylinder and reaming afirst end of the cylindrical bone. Then cutting the cylindrical bone toa desired length and reaming the second end of bone. The first end maybe reamed to have a concave shape and the second end to have a convexshape or the first end may be reamed to have a convex shape and thesecond end to have a concave shape.

These and other objects, features and advantages of this invention willbecome apparent from the following detailed description of the variousaspects of the invention taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of the specification, illustrate embodiments of the invention andtogether with the detailed description herein, serve to explain theprinciples of the invention. It is emphasized that, in accordance withthe standard practice in the industry, various features are not drawn toscale. In fact, the dimensions of the various features may bearbitrarily increased or reduced for clarity of discussion. The drawingsare only for purposes of illustrating preferred embodiments and are notto be construed as limiting the invention.

FIG. 1 is an isometric view of a pair of bone clamps, in accordance withan aspect of the present invention;

FIG. 2 is an exploded view of the bone clamps of FIG. 1, in accordancewith an aspect of the present invention;

FIG. 3 is an isometric view of a mating pair of jaws for the bone clampof FIG. 1, in accordance with an aspect of the present invention;

FIG. 4 is an isometric view of a piece of bone cut using the bone clampsof FIG. 1, in accordance with an aspect of the present invention;

FIG. 5A is an isometric view of a set of wedge shaped saw jigs, inaccordance with an aspect of the present invention;

FIG. 5B is a top view of the set of wedge shaped saw jigs of FIG. 5A, inaccordance with an aspect of the present invention;

FIG. 6 is an isometric view of one of the wedge shaped saw jigs of FIG.5 and a bone wedge cut using the saw jig, in accordance with an aspectof the present invention;

FIG. 7A is an isometric view of a wedge shaped bone segment with ananatomical profile, in accordance with an aspect of the presentinvention;

FIG. 7B is a distal side view of the wedge shaped bone segment of FIG.7A, in accordance with an aspect of the present invention;

FIG. 7C is a medial side view of the wedge shaped bone segment of FIGS.7A-7B, in accordance with an aspect of the present invention;

FIG. 7D is a plantar side view of the wedge shaped bone segment of FIGS.7A-7C, in accordance with an aspect of the present invention;

FIG. 7E is a lateral side view of the wedge shaped bone segment of FIGS.7A-7D, in accordance with an aspect of the present invention;

FIG. 8 is an isometric view of two prepared bone surfaces and the wedgeshaped bone segment of FIGS. 7A-7E with an anatomical profile, inaccordance with an aspect of the present invention;

FIG. 9 is a medial view of a right foot having the bone segment of FIGS.7A-7E implanted in the foot, in accordance with an aspect of the presentinvention;

FIG. 10A is an isometric view of a restoration bone segment, inaccordance with an aspect of the present invention;

FIG. 10B is a front view of a restoration bone segment, in accordancewith an aspect of the present invention;

FIG. 10C is a side view of a restoration bone segment, in accordancewith an aspect of the present invention;

FIG. 11 is an isometric view of a cup and cone reamers, two preparedbone surfaces, and a restoration bone segment of FIGS. 10A-10C, inaccordance with an aspect of the present invention;

FIG. 12 is an isometric view of another embodiment of a cup reamer andcover, in accordance with an aspect of the present invention;

FIG. 13 is an isometric top view of the cup reamer of FIG. 12, inaccordance with an aspect of the present invention;

FIG. 14 is an isometric bottom view of the cup reamer of FIG. 12, inaccordance with an aspect of the present invention;

FIG. 15 is an isometric view of the cup reamer cover of FIG. 12, inaccordance with an aspect of the present invention;

FIG. 16A is an isometric top view of another embodiment of a cone reamerand cover, in accordance with an aspect of the present invention;

FIG. 16B is an isometric bottom view of the cone reamer and cover ofFIG. 16A, in accordance with an aspect of the present invention;

FIG. 17 is an isometric side view of the cone reamer of FIGS. 16A and16B, in accordance with an aspect of the present invention;

FIG. 18 is an isometric bottom view of the cone reamer of FIG. 17, inaccordance with an aspect of the present invention;

FIG. 19 is an isometric bottom view of the cone reamer cover of FIGS.16A and 16B, in accordance with an aspect of the present invention;

FIG. 20 is a side view of two prepared bone surfaces and a concave andconvex shaped bone segment, in accordance with an aspect of the presentinvention;

FIG. 21 is a medial view of a right foot having the bone segment ofFIGS. 10A-10C implanted in the foot, in accordance with an aspect of thepresent invention;

FIG. 22 is a medial view of a right foot having the bone segments ofFIGS. 7A-7E and FIGS. 10A-10C implanted in the foot, in accordance withan aspect of the present invention;

FIG. 23 depicts one embodiment of a surgical method for implanting animplant device into a patient's body, in accordance with an aspect ofthe present invention;

FIG. 24 depicts another embodiment of a surgical method for implantingan implant device into a patient's body, in accordance with an aspect ofthe present invention.

DETAILED DESCRIPTION FOR CARRYING OUT THE INVENTION

In this application, the words proximal, distal, anterior or plantar,posterior or dorsal, medial and lateral are defined by their standardusage for indicating a particular part or portion of a bone orprosthesis coupled thereto, or directional terms of reference, accordingto the relative disposition of the natural bone. For example, “proximal”means the portion of a bone or prosthesis nearest the torso, while“distal” indicates the portion of the bone or prosthesis farthest fromthe torso. As an example of directional usage of the terms, “anterior”refers to a direction towards the front side of the body, “posterior”refers to a direction towards the back side of the body, “medial” refersto a direction towards the midline of the body and “lateral” refers to adirection towards the sides or away from the midline of the body.Further, specifically in regards to the foot, the term “dorsal” refersto the top of the foot and the term “plantar” refers the bottom of thefoot.

Similarly, positions or directions may be used herein with reference toanatomical structures or surfaces. For example, as the current devices,instrumentation and methods are described herein with reference to usewith the bones of the foot, the bones of the foot, ankle and lower legmay be used to describe the surfaces, positions, directions ororientations of the devices, instrumentation and methods. Further, thedevices, instrumentation and methods, and the aspects, components,features and the like thereof, disclosed herein are described withrespect to one side of the body for brevity purposes. However, as thehuman body is relatively symmetrical or mirrored about a line ofsymmetry (midline), it is hereby expressly contemplated that thedevices, instrumentation and methods, and the aspects, components,features and the like thereof, described and/or illustrated herein maybe changed, varied, modified, reconfigured or otherwise altered for useor association with another side of the body for a same or similarpurpose without departing from the spirit and scope of the invention.For example, the devices, instrumentation and methods, and the aspects,components, features and the like thereof, described herein with respectto the right foot may be mirrored so that they likewise function withthe left foot. Further, the devices, instrumentation and methods, andthe aspects, components, features and the like thereof, disclosed hereinare described with respect to the foot for brevity purposes, but itshould be understood that the devices, instrumentation, and methods maybe used with other bones of the body having similar structures, forexample the upper extremity, and more specifically, with the bones ofthe wrist, hand, and arm.

Referring to the drawings, wherein like reference numerals are used toindicate like or analogous components throughout the several views, andwith particular reference to FIGS. 1-3, there is illustrated anexemplary embodiment bone clamping device 10 for cutting an allograft orxenograft bone into a specific shape for creating bone segments forimplantation. The clamping device 10 having a first clamp 12, a secondclamp 14, a first jaw 16, and a second jaw 18. As best illustrated inFIGS. 1 and 2, the first clamp 12 and the second clamp 14 both having atop base 20, a bottom base 22, two guide rails 24, a clamping screw 26,a spacer 28, and a retaining screw 30. The top base 20 having a firstopening 32 for receiving the clamping screw 26, a pair of secondopenings 34 for receiving the two guide rails 24, and an attachmentmember 36 having a third opening 38 for attaching the first jaw 16. Thebottom base 22 having a first opening 32 for receiving the clampingscrew 26, a pair of second openings 34 for receiving the two guide rails24, and an attachment member 36 having a third opening 38 for attachingthe second jaw 18.

The first jaw 16 and the second jaw 18 have an outer anatomical profiledesigned to guide a cutting device, such as a saw blade, for cutting aallograft or xenograft bone into a shaft of bone 54 (See FIG. 4). Asdepicted in FIGS. 1-3, the first jaw 16 and second jaw 18 are shaped forcutting allograft or xenograft bone for creating Lapidus implants forinsertion at the tarsal-metatarsal joints, as well as for insertion intoother joints in the upper and lower extremity having similar shapes. Theclamping device 10 may also be used for cutting other bones havingvarious sizes and shapes by replacing the first jaw 16 and second jaw 18with differently shaped jaw members. For example, the clamping device 10may also be used for creating implants for insertion between the cuboidand calcaneous, within the calcaneous, and at the subtalar joint, aswell as in the upper extremity at the metacarpo-phalangeal joint,carpo-metacarpal joint and at other joints or bones within the humanbody. The first jaw 16 and second jaw 18 may have opposing serratedfaces 40 for clamping the allograft or xenograft bone during cutting. Asbest illustrated in FIG. 3, the first jaw 16 and second jaw 18 may alsohave a channel 42 in the back side of the first jaw 16 and second jaw 18and having a first side member 44 and a second side member 46 forsecuring the first jaw 16 and second jaw 18 to the attachment members 36of the top base 20 and bottom base 22. The first jaw 16 and second jaw18 having a first opening 50 and a second opening 52 which may be usedto secure the first jaw 16 and second jaw 18 to the attachment members36.

As best illustrated in FIGS. 1 and 2, the first jaw 16 is secured to theattachment member 36 of the top base 20 by a fastener 48, such as ascrew, and the second jaw 18 is secured to the attachment member 36 ofthe bottom base 22 by a fastener 48. The fasteners 48 pass through thethird opening 38 in the attachment members 36 and into the firstopenings 50 in the first jaw 16 and second jaw 18 to secure the firstjaw 16 and second jaw 18 to the attachment members 36. A piece ofallograft or xenograft bone, (Not Shown), may then be positioned on thesecond jaw 18 of the bottom base 22 for cutting. The piece of allograftor xenograft bone may preferably be a square, cylinder, or any shapehaving at least two parallel surfaces for being clamped between thefirst jaw 16 and the second jaw 18. The top base 20 may then be loweredalong the two guide rails 24 until the first jaw 16 contacts the top ofthe allograft or xenograft bone. Once the first jaw 16 and second jaw 18are in contact with the allograft or xenograft bone and the allograft orxenograft bone is positioned for cutting, the clamping screw 26 may betightened securing the allograft or xenograft bone in place in the firstclamp 12. The spacer 28 and retaining screw 30 may also be used tosecure the first clamp 12 before cutting the allograft or xenograftbone. Once the allograft or xenograft bone is captured between the firstjaw 16 and second jaw 18 of the first clamp 12, a cutting device, suchas a saw blade, preferably long enough to contact the first jaw 16 andthe second jaw 18 simultaneously, may trace around the outer profile ofthe first jaw 16 and second jaw 18. After the saw blade traces aroundthe outer profile with the first clamp 12 attached, the second clamp 14may be secured to the second jaw 18 at second opening 52 using afastener 48 as described above. Then the top base 20 may be slid intoplace in the first jaw 16, secured using clamping screw 26 of the secondclamp 14. A fastener 48 may be used to attach the attachment member 36of the top base 20 to the first jaw 16 at second opening 52. The firstclamp 12 may then be loosened and removed from the allograft orxenograft bone. Once the first clamp 12 is removed the user may then usea saw blade to trace around the outer profile of the uncut portion ofthe bone along the first jaw 16 and the second jaw 18. Once the secondcut is complete, a shaft of bone 54 with a profile matching that of thefirst jaw 16 and second jaw 18 is created, as best seen in FIG. 4. Asillustrated in FIG. 4, the shaft of bone 54 may have a shape whichcorresponds to the shape of the tarsal-metatarsal joints, which mayappear to have an oblong shape, more particularly a kidney bean shape orthe shape of any other target location in which the implant may beplaced.

As best seen in FIG. 5A, is a set of saw jigs 60 for creating bonewedges of various sizes. The saw jigs 60 having a plate 62 with anoblong shaped opening 64, more preferably Lapidus shaped as depicted,and a locking screw 66. The saw jigs 60 may be created in various sizesfor example preferably ranging from about 3 mm and 3° to about 20 mm to20° to correspond to various degrees of correction, as well as forexample 5 mm and 0° to about 20 mm and 0°. The saw jigs 60 may morepreferably range from about 5 mm and 5° to about 12 mm and 12° tocorrespond to the various degrees of correction, as well as for example14 mm and 0° to other thicknesses and angulations which may be cut to afinal size during a case intra-operatively. Other sizes are alsocontemplated which correspond to the patient's anatomy as well as othersizes with no angles which may be sized intra-operatively. The saw jigs60 include a first saw jig 70, a second saw jig 72, a third saw jig 74,a fourth saw jig 76, and a fifth saw jig 78, as depicted in theembodiment in FIGS. 5A-5B. The first saw jig 70 having a first end 140,a second end 142, and an angle 144 where for example the first end 140is about 5 mm and the angle 144 is about 5°. The second saw jig 72 has afirst end 146, a second end 148, and an angle 150 where for example thefirst end 146 is about 8 mm and the angle is about 8°. The third saw jig74 has a first end 152, a second end 154, and an angle 156 where thefirst end 152 is about 10 mm and the angle is about 10°. The fourth sawjig 76 has a first end 158, a second end 160, and an angle 162 where forexample the first end 158 is about 12 mm and the angle 162 is about 12°.The fifth saw jig 78 has a first end 164 and a second end 166 with auniform thickness where for example the first end 164 and second end 166are about 14 mm. The saw jigs 60 wherein where the first ends 140, 146,152, 158, and 164 are opposite the second ends 142, 148, 154, 160, and166. The shaft of bone 54 which was cut using the clamping device 10, asseen in FIG. 4, would be inserted into the opening 64 of one of the setof saw jigs 60 having the desired dimensions for implantation and theshaft of bone 54 would be secured using the locking screw 66. Then aband saw blade or other cutting device, not shown, could be operatedalong both sides of the saw jig selected from the set of saw jigs 60creating a bone wedge 80. The bone wedge 80 may be cut using the sawjigs 60 to mimic the anatomical considerations of the bones the bonewedge 80 is being inserted between with the desired angular correctionsfor a given procedure.

Referring now to FIGS. 6-9, an example of the bone wedge 80 which may becut from the first saw jig 70 is shown. The bone wedge 80 has a profileidentical to the Lapidus shaped opening 64 of the first saw jig 70.Illustrated in FIGS. 7A-7E, are an isometric view, a distal side view, amedial side view, a plantar side view, and a lateral side view of thebone wedge 80, respectively. The bone wedge 80 is cut to a desiredrestoration length necessary for the patient receiving the implant andhas an outer anatomical profile that mimics the anatomicalconsiderations of the bones it is being inserted between. For example,as depicted in FIGS. 8 and 9, the outer anatomical profile of the bonewedge 80 on the proximal and distal sides is cut to mimic the shapes ofthe medial cuneiform 82 and metatarsal 84 bones, which is an oblongshape, or more preferably is a kidney shape. In addition, the bone wedge80 is cut with a desired angle thereby creating a desired angular offsetbetween the medial cuneiform 82 and the metatarsal 84. The bone wedge 80may be cut in the saw jigs 70, 72, 74, or 76 to create a wedge geometryhaving reproducible angular corrections which are desired for a givenprocedure. For example, in the Lapidus implant the desired angulationmay be used to correct valgus and plantar angulation of the bones bytapering the bone wedge 80 from the medial side to the lateral side andfrom the dorsal side to the plantar side. The bone wedge 80 may haveheights ranging from about 25 mm to 40 mm, width ranging from about 10mm to 30 mm, and thickness ranging from about 0 mm to 20 mm at thedorsal side and the medial side and tapering from the dorsal side toplantar side and medial side to lateral side at an angle ranging fromabout 0° to 20°. More preferably, the bone wedges 80 have heights ofabout 32 mm, a width of about 21 mm at the dorsal medial corner, andfunctional thickness of 5 mm and 5°, 8 mm and 8°, 10 mm and 10°, 12 mmand 12°, and 14 mm and 0°. It is also contemplated that the taper of thethickness of the bone wedge 80 may be from the dorsal-medial corner tothe plantar-lateral corner.

As seen in FIGS. 7D-7E, the bone wedge 80 is tapered in themedial-lateral plane from the medial side 86 of the bone wedge 80 to thelateral side 88 and in the dorsal-planatar plane from the dorsal side 90of the bone wedge 80 to the plantar side 92. More particularly, the bonewedge 80 may be tapered from the dorsal-medial corner to plantar-lateralcorner of the Z-axis. Thus, a bi-planar surface is created on the bonewedge 80 wherein the proximal surface converges towards the distalsurface. The bone wedge 80 may be cut from bone for example cancellousbone and/or a combination of cortical or cancellous bone, or may be madeof metal, for example a titanium material, or may be made of a polymeror composite, for example a polyetheretherketone (“PEEK”) material, orother material appropriate for implantation. In the event allograft orxenograft bone is used it may be minimally processed allograft orxenograft bone having stout cancellous or cancellous and cortical boneand is used for retaining maximum osteoinductivity. The minimallyprocessed allograft or xenograft bone is not gamma irradiated topreserve mechanical integrity and is not exposed to peroxides topreserve osteoinductivity.

A surgical method for implanting the bone wedge 80 into a joint, shownin FIG. 23, will now be described. The method utilizes some of thedevices, instruments, features, aspects, components and the likedescribed above, and therefore reference will be made to the abovedescribed embodiments, such as the illustrated embodiments presented inthe figures and discussed above. However, such references are made forexemplary purposes only and are not intended to limit the surgicalmethod beyond the specifically recited steps. Further, the surgicalmethod may be discussed under the umbrella of particular bones, but suchan application is not intended to be limiting and the method describedherein may be used or conducted with bone or other tissue notspecifically discussed herein without departing from the spirit andscope of the surgical method.

Assuming the patient has a hallux valgus deformity which needs to becorrected, an implant device, such as bone wedge 80, and fixationmembers, such as pins, screws, plates, or external fixation may be usedto correct the deformity. For example, the hallux may be pointingoutward away from the midline of the body and need to be realigned,wherein the first metatarsal and phalanx may be angled away from themidline of the body and towards the other toes. As the first metatarsaland medial cuneiform are being used for exemplary purposes only, thegeneric term “first bone” may be used hereinafter to refer to the firstmetatarsal bone, or any other bone that includes similar features,positioning, orientation, function or the like. Similarly, the genericterm “second bone” may be used hereinafter to refer to the medialcuneiform, or any other bone that includes similar features,positioning, orientation, function or the like. Likewise, the genericterm “first joint” may be used hereinafter to refer to the joint betweenthe first metatarsal and the medial cuneiform, or any other joint thatincludes similar features, positioning, orientation, function or thelike.

As illustrated in FIG. 23, in order to correct the deformity in thefirst and second bones, an implant cavity will first be formed at thefirst joint, whereby the first joint is exposed so the first and secondbones may be prepared for the arthrodesis. The first bone will then becut to remove the cartilage from the base of the first bone. Next, thesecond bone will be cut to remove the cartilage from the distal aspectof the second bone. The cut to the second bone should be performed at a45° angle dorsal medial to plantar lateral to provide two planes ofcorrection to the first and second bones. Once the first and second bonehave been prepared the surgeon may either select a bone wedge 80 from akit containing a set of various sizes of bone wedges and implant thebone wedge 80 having the desired width and angle. Alternatively, if adifferent size bone wedge is needed the surgeon may select the bonewedge 80 from the kit having a uniform size and cut a custom bone wedge,(Not Shown), for the desired site intra-operatively. Once a bone wedge80 has been selected it may then be inserted between the first andsecond bones and aligned to correct the deformity of the bones. Afterthe correct alignment has been achieved the bone wedge 80 must be fixedwithin the first joint with one or more fixation devices. The fixationdevices may include screws, wires, plates, or external fixation. Oncethe bone wedge 80 is secured within the first joint the skin incisionmay be closed up by the surgeon.

One advantage of the embodiments discussed herein of the presentinvention is that the bone wedge 80 enables correction in both thedorsal-plantar plane and medial-lateral plane. Alternatively and morespecifically, the bone wedge 80 may provide angulation from thedorsal-medial plane to the plantar-lateral plane. In addition, theLapidus procedure allows for plantar angulation of the first ray torestore weight distribution back to the sesamoids. The custom allograftbone wedge 80 is designed to mimic the oblong shape of the joint, moreparticularly the kidney bean shape of the joint, and restore theangulation of the wedge to 45 degrees from the z-axis to provide bothplantar and valgus angulation of the proximal phalanx. Another advantageof the embodiments of the present invention discussed herein is that thebone wedge 80 may be composed of the most robust cancellous orcancellous and cortical structure and will preserve the structure andosteoinductivity of the adjacent bones. A further advantage of thepresent invention discussed herein is that the bone wedge 80 may be usedto correct a number of deformities in various joints and bones of theupper and lower extremities.

Referring now to FIGS. 10A-21, illustrated in these figures are variousimplants and surgical instruments including cup and cone reamers and arestoration bone segment. Best seen in FIGS. 10A-10C, is a restorationbone segment 100 which may be used for insertion between two bonesegments to adjust their overall length. The restoration bone segment100 may be cut from bone, for example cancellous bone or combinationcancellous/cortical bone, may be made of metal, for example a titaniummaterial, or may be made of a polymer or composite, for example apolyetheretherketone (“PEEK”) material. The allograft or xenograft boneis a minimally processed allograft or xenograft bone having stoutcancellous bone or cancellous and cortical bone and is used to maintainmaximum osteoinductivity. The restoration bone segment 100 has a concaveend 102 for mating with a convex bone 108 and a convex end 104 formating with a concave bone 106, as depicted in FIG. 11. The restorationbone segment 100 may be made using a cone reamer 110 and a cup reamer112 which creates a ball and socket like configuration. To create therestoration bone segment 100, a cylindrical piece of bone having thedesired circumference may have a convex end 104 created using the conereamer 110, then the bone may be cut to the desired length and the cupreamer 112 may be used to create the concave end 102. Alternatively, thepiece of bone may have the concave end 102 created using the cup reamer112, then the bone may be cut to the desired length and the cone reamer110 used to create the convex end 104. In addition, the cone reamer 110and cup reamer 112 may be used to prepare the bones for insertion of therestoration bone segment 100, described in greater detail hereinafter.

Another embodiment of the cone reamer 110 is depicted in FIG. 12. Thecone reamer 110 has a shank 114 for insertion into a drill, a cuttingedge 116 for cutting a convex shape into bone, and a backstop 118 toprotect the opposite side from damage during reaming. As illustrated inFIGS. 13 and 14, it is also contemplated that the cone reamer 110 may beused without the backstop 118, seen in FIG. 15. Various size cuttingedges 116 may be provided based on the desired diameter of the convexend 104 of the bone segment 100 and corresponding convex bone 108. Theinner diameter of the cutting edge 116 corresponds to the outer diameterof the bone cut with the cone reamer 110.

Illustrated in FIGS. 16A-16B is another embodiment of the cup reamer112. The cup reamer 112 has a shank 120 for insertion into a drill, acutting edge 122 for cutting a concave shape into a bone, and a backstop124 to protect the opposite side from damage during reaming. It is alsocontemplated and depicted in FIGS. 17-18 that the cup reamer 112 may beused without the backstop 124, seen in FIG. 19. Various size cuttingedges 122 may be provided based on the desired diameter of the concaveend 102 of the bone segment 100 and corresponding concave bone 106. Theouter diameter of the cutting edge 122 corresponds to the inner diameterof the bone cut with the cup reamer 112.

Referring now to FIG. 20, the restoration bone segment 100 is shownaligned with the corresponding bones for implantation. The first bonebeing a concave bone 106 for mating with the convex end 104 of the bonesegment 100 and the second bone being a convex bone 108 for mating withthe concave end 102 of the bone segment 100. The cone reamer 110 and cupreamer 112 may have cutting edges 116 and 122, respectively, ranging forexample from about 10 mm to 24 mm, with the most preferred dimensionsfor correction at the metatarsal-phalangeal joints being for exampleabout 19 mm to 21 mm. As depicted in FIG. 21, the bone segment 100 maybe inserted between the proximal phalanx 130 and the first metatarsal84. In the depicted embodiment, the proximal end of the phalanx 130 isthe concave bone 106 which mates with the convex end 104 of the bonesegment 100, while the distal end of the first metatarsal 84 is theconvex bone 108 which mates with the concave end 102 of the bone segment100 to create a ball and socket configured metatarsal-phalangeal joint134. By using an implant with a concave end 102 and a convex end 104 theamount of bone resection of the metatarsal-phalangeal joint 134 isminimized. In addition, the use of the bone segment 100 enableslengthening of the first metatarsal 84 before the metatarsal-phalangealjoint 134 is fused to help maintain a normal gait for the patient. Thediameter of the bone segment 100 for use in the metatarsal-phalangealjoint 134 may range from for example about 10 mm to 24 mm, with the morepreferable dimensions being for example about 19 mm to 21 mm. Thethickness of the bone segment 100 for use in the metatarsal-phalangealjoint 134 may range from about 5 mm to about 20 mm for a bone segment100. It is also contemplated that the bone segment 100 may be used inother joints and bones of the lower extremity, as well as in the jointsand bones of the upper extremity.

A surgical method for implanting the bone segment 100 into a joint, asseen in FIG. 24, will now be described. The method utilizes some of thedevices, instruments, features, aspects, components, and the likedescribed above, and therefore reference will be made to the abovedescribed embodiments, such as the illustrated embodiments presented inthe figures and discussed above. However, such references are made forexemplary purposes only and are not intended to limit the surgicalmethod beyond the specifically recited steps. Further, the surgicalmethod may be discussed under the umbrella of particular bones, but suchan application is not intended to be limiting and the method describedherein may be used or conducted with bone or other tissue notspecifically discussed herein without departing from the spirit andscope of the surgical method.

Assuming the patient has a shortened bone which needs to be corrected,an implant device, such as bone segment 100, and a fixation member maybe used to correct the deformity. The fixation member may include one ormore plates, screws, wires, or external fixation. For example, the firstmetatarsal and phalanx may have been shortened due to several reasons,such as a hallux valgus deformity, a revision surgery due to a failedprior surgery, a non-union, or a generally short anatomy. All of theseresulting in a shortened first metatarsal, which may be affecting theperson's gait. As the phalanx and first metatarsal are being used forexemplary purposes only, the generic term “first bone” may be usedhereinafter to refer to the phalanx bone, or any other bone thatincludes similar features, positioning, orientation, function or thelike. Similarly, the generic term “second bone” may be used hereinafterto refer to the first metatarsal bone, or any other bone that includessimilar features, positioning, orientation, function or the like.Likewise, the generic term “first joint” may be used hereinafter torefer to the joint between the phalanx and the first metatarsal, or anyother joint that includes similar features, positioning, orientation,function or the like.

As best illustrated in FIG. 24, in order to correct the deformity in thefirst and second bones, an implant cavity will first be formed at thefirst joint, whereby the first joint is exposed and the first and secondbones are prepared. The first bone may be prepared by reaming the firstbone to remove the cartilage from the proximal surface of the first bonethereby giving the proximal end of the first bone a concave surface.Next, the second bone may be prepared by reaming to remove the cartilagefrom the distal surface of the second bone, thereby giving the proximalend of the second bone a convex surface. Once the first and second boneshave been prepared, the surgeon may select a bone segment 100, having aconcave end 102 and a convex end 104, from a kit containing a set ofeach of various sizes of bone segments 100 which have variouscircumferences and thicknesses. Alternatively, the surgeon may select acylinder of bone from the kit having a desired circumference and use thecup reamer 112 and cone reamer 110 to cut a bone segment 100 for thedesired site intra-operatively. The surgeon then inserts the convex end104 of the bone segment 100 into the concave surface of the first boneand fits the concave end 102 of the bone segment 100 over the convexsurface of the second bone. Alternatively, the concave end 102 of thebone segment 100 may be inserted over the convex surface of the secondbone and then the convex end 104 of the bone segment 100 inserted intothe concave surface of the first bone. Once the bone segment 100 hasbeen inserted the combined length of the first and second bones will beincreased and the first and second bones aligned to a desired position.After the two bones are aligned and a final position is determined, aremovable fixation device, such as a guide wire, may be used to securethe bone segment 100 while additional fixation is applied. Theadditional fixation of the bone segment 100 may be accomplished with oneor more plates, screws, wires, or external fixation devices. Once thebone segment 100 is secured within the first joint, the incision may beclosed by the surgeon.

One advantage of the embodiments of the present invention discussedherein is that the bone segment 100 will allow for manipulation of thejoint to provide optimal positioning prior to applying fixation. Themetatarsal-phalangeal bone segment 100 having a concave end and a convexend allows the surgeon to precisely position the toe with dorsiflexionand valgus specifications without the requirement of additional boneresection. The bone segment 100 may be made from allograft or xenograftbone that is robust in cancellous structure and which has only beenminimally processed to maintain maximum osteoinductivity.

An example of the placement of the bone wedge 80 of FIGS. 7A-7C andrestoration bone segment 100 of FIGS. 10A-10C in the hallux areillustrated in FIG. 22. The restoration bone segment 100 may be used toadjust the length of the metatarsal-phalangeal joints or other similarjoints in the upper and lower extremities. If length of the firstmetatarsal 84 is lost, the weight distribution on the patient's sesamoidbones may change which ultimately results in a change in how the patientwalks. In order to address both the potential for functional loss of thesesamoid bones as well as a shortening of the phalanx, the presentdisclosure includes placement of the bone wedge 80 at thetarsal-metatarsal joint 136 and the restoration bone segment 100 at themetatarsal-phalangeal joint 138. The bone wedge 80 and the restorationbone segment 100 require additional fixation methods to secure themwithin the tarsal-metatarsal joint 136 and the metatarsal-phalangealjoint 138, respectively. Such fixation methods may include bone screws,wires, bone plates, external fixation, or the like. The bone wedge 80and restoration bone segment 100 may also be used in other similarjoints, for example the tarsal-metatarsal joints andmetatarsal-phalangeal joints of the small toes as well as themetacarpo-phalangeal joint, carpo-metacarpal joint and other joints ofthe upper extremity. In addition, the bone wedge 80 may be usedindependently to correct deformities at the tarsal-metatarsal joint 136and other similar joints in the upper and lower extremities. Likewise,the bone segment 100 may be used independently to correct deformities atthe metatarsal-phalangeal joint 138 and other similar joints in theupper and lower extremities.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprise” (andany form of comprise, such as “comprises” and “comprising”), “have” (andany form of have, such as “has”, and “having”), “include” (and any formof include, such as “includes” and “including”), and “contain” (and anyform of contain, such as “contains” and “containing”) are open-endedlinking verbs. As a result, a method of device that “comprises,” “has,”“includes,” or “contains” one or more steps or elements possesses thoseone or more steps or elements, but is not limited to possessing onlythose one or more steps or elements. Likewise, a step of a method or anelement of a device that “comprises,” “has,” “includes,” or “contains”one or more features possesses those one or more features, but is notlimited to possessing only those one or more features. Furthermore, adevice or structure that is configured in a certain way is configured inat least that way, but may also be configured in ways that are notlisted.

The invention has been described with reference to the preferredembodiments. It will be understood that the architectural andoperational embodiments described herein are exemplary of a plurality ofpossible arrangements to provide the same general features,characteristics, and general system operation. Modifications andalterations will occur to others upon a reading and understanding of thepreceding detailed description. It is intended that the invention beconstrued as including all such modifications and alterations.

1. A surgical method for implanting an implant with a first end and asecond end into a joint, comprising: exposing the joint of a patient;separating a first bone from a second bone; reaming the first bone;reaming the second bone; and inserting a bone implant between the firstbone and the second bone.
 2. The method of claim 1, wherein the firstbone is reamed to have a convex shape and the second bone is reamed tohave a concave shape.
 3. The method of claim 2, wherein the concave endof the implant configured to mate with the convex shape of the firstbone and the convex end of the implant is configured to mate with theconcave shape of the second bone.
 4. The method of claim 3, wherein thefirst bone is a phalanx and the second bone is a metatarsal.
 5. Themethod of claim 1, wherein the first bone is reamed to have a concaveshape and the second bone is reamed to have a convex shape.
 6. Themethod of claim 5, wherein the convex end of the implant mates with theconcave shape of the first bone and the concave end of the implant mateswith the convex shape of the second bone.
 7. The method of claim 1,further comprising: securing the implant to the first bone and thesecond bone by securing a fixation device over the implant and attachingit to the first bone and the second bone.
 8. The method of claim 1,wherein reaming the first bone comprises: obtaining a cup reamer; andreaming the first bone to form a concave end.
 9. The method of claim 8,wherein the cup reamer comprises: a shank; and a cutting portion coupledto a distal end of the shank.
 10. The method of claim 9, wherein thecutting portion comprises: a plurality of cutting edges having a convexcutting surface.
 11. The method of claim 10, wherein the cup reamerfurther comprises: a backstop removably coupled on the shank andpositioned over the cutting portion to protect surrounding soft tissuefrom the cutting edges.
 12. The method of claim 1, wherein reaming thesecond bone comprises: obtaining a cone shaped reamer; and reaming thesecond bone to form a convex end.
 13. The method of claim 12, whereinthe cone shaped reamer comprises: a shank; and a cutting portion coupledto a distal end of the shank.
 14. The method of claim 13, wherein thecutting portion comprises: a plurality of cutting edges having a concavesurface.
 15. The method of claim 14, wherein the cone shaped reamerfurther comprises: a backstop removably coupled on the shank andpositioned over the cutting portion to protect surrounding soft tissueform the cutting edges.
 16. The method of claim 6, wherein the firstbone is a metatarsal and the second bone is a phalanx.